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United States Patent | 6,214,373 |
Snowden | April 10, 2001 |
A nutritional composition and method useful for treatment of inflammatory bowel diseases is disclosed, the composition comprising selected vitamins and mineral salts for oral administration to a subject having an inflammatory bowel disease. The composition comprises an excess of vitamin D and vitamin B.sub.12, contains vitamin C and iron in quantities promoting good absorption, contains water miscible forms of the fat soluble vitamins, and no phosphate or carbonate salts. Preferably, the iron is present as ferrous fumarate. And, preferably the composition is essentially free of magnesium.
Inventors: | Snowden; Robert B. (Churchville, PA) |
Assignee: | Snowden-Sutton Associates, Inc. (Churchville, PA) |
Appl. No.: | 414666 |
Filed: | October 7, 1999 |
Current U.S. Class: | 424/439; 424/400; 424/442; 424/451; 424/464; 424/465 |
Intern'l Class: | A61K 047/00 |
Field of Search: | 424/400,439,442,451,464,465 |
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Harrison's Principles of Internal Medicine, 12th Ed., vol. 2, McGraw-Hill, Inc., pp. 1268-1281, 1991. Franklin, et al., Impaired Folic Acid Absorption in Inflammatory Bowel Disease: Effects of Salicylazosulfapyridine (Azulfidine), vol. 64, No. 4, Gastroenterology, pp. 517-525, Apr. 1973. Linaker, Scurvy and Vitamin C Deficiency in Chron's Disease Postgraduate Medical Journal (Jan. 1979), vol. 55, pp. 26-29. Nugent, et al., Malignant Potential of Chronic Ulcerative Colitis, American Gastroenterology Association, 1979, vol. 76(1), pp. 1-5. Penny, et al., Relationship Between Trace Elements, Sugar Consumption, and Taste in Chron's Disease, Gut. 1983, vol. 24, pp. 288-292. McClain, et al., Zinc-Deficiency-Induced Retinal Dysfunction in Chron's Disease, Digestive Diseases and Sciences, vol. 28, No. 1 (Jan. 1983), pp. 85-87., ",". Harries, et al., Nutritional Disturbances in Chron's Disease, Postgraduate Medical Journal (Nov. 1983), vol. 59, pp. 690-697. FernandezBanares, et al., Vitamin Status in Patients with Inflammatory Bowel Disease, The American Journal of Gastroenterology, vol. 84, No. 7, 1989, pp. 744-748. Vogelsang, et al., Bone Disease in Vitamin D-Deficient Patients with Chron's Disease, Digestive Diseases and Sciences, vol. 34, No. 7 (Jul. 1989), pp. 1094-1099., ",". Recommended Dietary Allowances, 10th Ed., National Academy Press, Washington, DC 1989, "Fat-Soluble Vitamins", pp. 78-92, "Water-Soluble Vitamins", p. 115, pp. 169-185, pp. 212-217. Ivey, et al., Nutritional Supplement, Mineral, and Vitamin Products, "Handbook of Nonprescription Drugs", 9th Ed., American Pharmaceutical Association, 1990, pp. 447-480. Heatley, Assessing Nutritional State in Inflammatory Bowel Disease, Gut 1986, vol. 27, S1, pp. 61-66. Collins, et al., Colon Cancer, Dysplasia, and Surveillance in Patients with Ulcerative Colitis, The New England Journal of Medicine, Jun. 1987, vol. 316, pp. 1654-1658. Nakamura, et al., Zinc Clearance Correlates with Clinical Severity of Chrons's Disease a Kinetic Study, Digestive Diseases and Sciences, vol. 33, No. 12 (Dec. 1988) pp. 1520-1524. Sturniolo, et al., Zinc Absorption in Chron's Disease, Gut, 1980, vol. 21, pp. 387-391. Lashner, et al., Effect of Folate Supplementation on the Incidence of Dysplasia and Cancer in Chronic Ulcerative Colitis, Gastroenterology, 1989, vol. 97, pp. 255-259. Rosenberg, et al., Folate, Dysplasia, and Cancer, Gastroenterology, 1989, vol. 97, pp. 502-503. Lederle, F., Oral Cobalamin for Pernicious Anemia, Jama, Jan. 1991, vol. 265, No. 1, pp. 94-95. Hathcock, et al., Oral Cobalamin for Treatment of Pernicious Anemia?, Jama, Jan. 1991, vol. 265, No. 1, pp. 96-97. |
TABLE 1 Vitamin A 1,500 to 5,000 IU Vitamin D 200 to 600 IU Vitamin E 15 to 100 IU Vitamin K 15 to 60 mcg Vitamin C 30 to 150 mg Vitamin B.sub.1 1 to 6 mg Vitamin B.sub.2 1 to 6 mg Vitamin B.sub.6 1 to 6 mg Vitamin B.sub.12 150 to 1,000 mcg Folic Acid 0.2 to 0.5 mg Niacin 5 to 20 mg Biotin 0.1 to 0.2 mg Pantothenic acid 2 to 8 mg Iron 6 to 20 mg Calcium 50 to 200 mg Zinc 5 to 15 mg Selenium 20 to 50 mcg Copper 0.5 to 1.5 mg Iodine 60 to 80 mcg Manganese 0.5 to 1.5 mg
TABLE 2 Vitamin A (retinyl acetate) 2,500 IU Vitamin D (cholecalciferol) 400 IU Vitamin E (dl-alpha tocopherol acetate) 75 IU Vitamin K (phytonadione) 40 mcg Vitamin C (ascorbic acid) 100 mg Vitamin B1 (thiamine mononitrate) 5 mg Vitamin B2 (riboflavin) 5 mg Vitamin B6 (pyridoxine hydrochloride) 5 mg Vitamin B12 (cyanocobalamin) 500 mcg Folic Acid 0.2 mg Niacin (niacinamide) 10 mg Biotin 0.15 mg Pantothenic acid 5 mg Iron 15 mg Calcium 100 mg Zinc 11.25 mg Selenium 35 mcg Copper 1.0 mg Iodine 75 mcg Manganese 1.0 mg